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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT
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DENTIUMUSA IMPLANTIUM; DENTAL IMPLANT Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The dental implant fx4308mlc was removed on (b)(6) 2019 due to failure to osseointegrate 3 months after implantation.The patient has no significant medical history.The patient required bone augmentation for the operation.The doctor noted bone resorption during explantation.The patient required another surigcal intervention to recover.
 
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Brand Name
IMPLANTIUM
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
DENTIUMUSA
6761 katella ave
cypress CA 90630
MDR Report Key9593645
Report Number3005503242-2020-00001
Device Sequence Number3080382
Product Code DZE
UDI-Device IdentifierD755FX4308MLC0
UDI-PublicD755FX4308MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date10/19/2023
Device Model NumberFX4308MLC
Device Catalogue NumberFX4308MLC
Device Lot NumberI16SA962S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2020
Initial Report FDA Received Date01/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age53 YR
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